Label: ONE PERCENT SUNSCREEN cream

  • NDC Code(s): 85176-001-01
  • Packager: Beijing Keyan Biotechnology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 5, 2025

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  • Active Ingredient(s)

    ZINC OXIDE 10.45%

    ETHYLHEXYL METHOXYCINNAMATE 8.49405%

    TITANIUM DIOXIDE 3.9%

    ALUMINUM HYDROXIDE 0.6%

    ETHYLHEXYL SALICYLATE 4%

    PHENYLBENZIMIDAZOLE SULFONIC ACID 1%

  • Purpose

    Sunscreen

  • Use

    helps prevent sunburn. if used as directed with other sun protection measures (see Directions).
    decreases the risk of skin cancer and early skin aging caused by the sun.

  • Warnings

    For external use only.

  • Do not use

    Do not use on damaged or broken skin.

  • WHEN USING

    When using this product
    keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Posion Control Center right away.
    May stain some fabrics.

  • Directions

    1. Clean the face
    2. Moisturizing and hydrating
    3. Apply sunscreen

  • Other information

    Other information protect this product from excessive heat and direct sun

  • Inactive ingredients

    WATER, CYCLOPENTASILOXANE, TRIETHOXYCAPRYLYLSILANE, DIMETHICONE, GLYCERIN, SODIUM CHLORIDE,

    TRIETHANOLAMINE, BHT, ISODODECANE, STEARIC ACID, PHENYL TRIMETHICONE, POLYMETHYLSILSESQUIOXANE,

    BUTYLENE GLYCOL, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, SILICA, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, TRIMETHYLSILOXYSILICATE,

    PHENOXYETHANOL, DISTEARDIMONIUM HECTORITE, DEXTRIN PALMITATE, PROPYLENE CARBONATE,

    ETHYLHEXYLGLYCERIN

  • Package Label - Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    ONE PERCENT SUNSCREEN 
    one percent sunscreen cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85176-001
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ETHYLHEXYL METHOXYCINNAMATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51) ETHYLHEXYL METHOXYCINNAMATE8.49405 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.9 g  in 100 mL
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE0.6 g  in 100 mL
    ETHYLHEXYL SALICYLATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W) ETHYLHEXYL SALICYLATE4 g  in 100 mL
    PHENYLBENZIMIDAZOLE SULFONIC ACID (UNII: 9YQ9DI1W42) (PHENYLBENZIMIDAZOLE SULFONIC ACID - UNII:9YQ9DI1W42) PHENYLBENZIMIDAZOLE SULFONIC ACID1 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10.45 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SILICA (UNII: ETJ7Z6XBU4)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE (UNII: PWZ1720CBH)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYMETHYLSILSESQUIOXANE (UNII: 59Z907ZB69)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE SALICYLATE (UNII: H8O4040BHD)  
    BHT (UNII: 1P9D0Z171K)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ISODODECANE (UNII: A8289P68Y2)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85176-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product02/05/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/05/2025
    Labeler - Beijing Keyan Biotechnology Co., Ltd. (722193632)
    Establishment
    NameAddressID/FEIBusiness Operations
    Beijing Keyan Biotechnology Co., Ltd.722193632manufacture(85176-001)
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